Clinical Trial Protocol Iranian Registry of Clinical Trials

30 Sep 2021

Evaluation of complications, and safety of ligamentous hemorrhoidectomy in comparison with conventional hemorrhoidectomy

Protocol summary Last update: 2020-05-04, 1399/02/15 Update count: 0 Study aim Registration date Comparison of the side eﬀects and safety of 2020-05-04, 1399/02/15 hemorrhoidectomy with Ligasure compared to conventional hemorrhoidectomy Registrant information Design Name Clinical trial with control group, with parallel group; Zabihullah Mohaghegh Double blind, randomized Name of organization / entity Settings and conduct Country This study is being performed at Imam Reza Hospital in Iran (Islamic Republic of) Birjand, South Khorasan Province. 54 patients are Phone randomly divided into two groups: Ligasure surgery and +98 56 3232 3232 Ferguson method. Then the amount of pain in patients in Email address two groups in the hours of 24, 12, 6 and 0 after surgery, [email protected] postoperative complications in patients including: urinary Recruitment status retention, the amount of postoperative bleeding, The Recruitment complete duration of hospitalization in the ward will be Funding source incontinence and defecation, nausea and vomiting, which will be examined by the nurse without surgery and one day after the operation without the patient's knowledge Expected recruitment start date of the type of surgery. 2020-03-20, 1399/01/01 Participants/Inclusion and exclusion criteria Expected recruitment end date Inclusion criteria: Lack of Disease of liver, kidney, 2020-06-19, 1399/03/30 bronchial asthma, gestational hypertension, Actual recruitment start date preeclampsia, and coagulation disorders empty Intervention groups Actual recruitment end date Patients who are candidates for hemorrhoid surgery are empty divided into two groups: Ferguson with 27 patients or the Trial completion date Ligasure group with 27 patients. empty Main outcome variables Scientiﬁc title the pain Complications after surgery Bleeding Evaluation of complications, and safety of ligamentous hemorrhoidectomy in comparison with conventional General information hemorrhoidectomy

Reason for update Public title Acronym Comparison of the eﬀects of hemorrhoidectomy with IRCT registration information Ligasure method with Ferguson method IRCT registration number: IRCT20190618043934N3 Purpose Registration date: 2020-05-04, 1399/02/15 Treatment Registration timing: registered_while_recruiting Inclusion/Exclusion criteria

1 Inclusion criteria: Health conditions studied Lack of Disease of liver Lack of Disease kidney Lack of Disease of bronchial asthma Lack of Disease of gestational hypertension Lack of Disease of preeclampsia 1 Lack of Disease of coagulation disorders Description of health condition studied Exclusion criteria: Hemorrhoid Disease Dissatisfaction with participating in the study concurrent ICD-10 code hemorrhoids with other pre-anal problems any other K64 unpredictable event for patients ICD-10 code description Age Hemorrhoids and perianal venous thrombosis No age limit Gender Primary outcomes Both

Phase 1 N/A Description Groups that have been masked Pain Timepoint Participant 0, 6, 12 and 24 hours after surgery Investigator Method of measurement Sample size Using the VAS ruler Target sample size: 27 Randomization (investigator's opinion) Secondary outcomes Randomized empty Randomization description Blocking method of Simple random sampling Intervention groups Blinding (investigator's opinion) Double blinded Blinding description 1 Participants in the study interferer Description Placebo Intervention group 1: Ligasure surgery is performed by Not used general surgery. Assignment Category Parallel Treatment - Surgery Other design features 2 Secondary Ids Description empty Intervention group 2: Ferguson surgery is performed by general surgery. Ethics committees Category Treatment - Surgery

1 Recruitment centers Ethics committee Name of ethics committee 1 Ethics Committee of Birjand University of Medical Recruitment center Sciences Name of recruitment center Street address Imam Reza Hospital_Birjand Moallem BLV Full name of responsible person City Mohammad Yaser Dadpour Rodi Birjand Street address Province Moallem Str South Khorasan City Postal code Birjand 9717811674 Province Approval date South Khorasan 2020-01-27, 1398/11/07 Postal code Ethics committee reference number 9717811674 Ir.bums.REC.1398.336 Phone

2 +98 56 3232 3232 South Khorasan Email Postal code [email protected] 9717811674 Phone Sponsors / Funding sources +98 56 3232 3232 Email [email protected] 1 Sponsor Person responsible for scientiﬁc Name of organization / entity inquiries Birjand University of Medical Sciences Full name of responsible person Contact Dr. Tooba Kazemi Name of organization / entity Street address Birjand University of Medical Sciences Ghaﬀari Str Full name of responsible person City Mohsen Najmaddini Birjand Position Province Member of the Faculty South Khorasan Latest degree Postal code Specialist 9717811674 Other areas of specialty/work Phone General Surgery +98 56 3238 1200 Street address Email Taleghani Str [email protected] City Grant name Birjand Grant code / Reference number Province Is the source of funding the same sponsor South Khorasan organization/entity? Postal code Yes 9717811674 Title of funding source Phone Birjand University of Medical Sciences +98 56 3232 3232 Proportion provided by this source 100 Email Public or private sector [email protected] Public Web page address Domestic or foreign origin Domestic Person responsible for updating data Category of foreign source of funding empty Contact Country of origin Name of organization / entity Type of organization providing the funding Birjand University of Medical Sciences Academic Full name of responsible person Zabihullah Mohaghegh Person responsible for general inquiries Position Student Contact Latest degree Name of organization / entity Bachelor Birjand University of Medical Sciences Other areas of specialty/work Full name of responsible person General Practitioner Zabihullah Mohaghegh Street address Position Moallem St Student City Latest degree Birjand Bachelor Province Other areas of specialty/work South Khorasan General Practitioner Postal code Street address 9717811674 Moallaem St Phone City +98 56 3232 3232 Birjand Email Province [email protected]

3 Sharing plan Informed Consent Form Undecided - It is not yet known if there will be a plan to Deidentiﬁed Individual Participant Data Set (IPD) make this available No - There is not a plan to make this available Clinical Study Report Justiﬁcation/reason for indecision/not sharing IPD Undecided - It is not yet known if there will be a plan to There is no need to publish individual patient information make this available Study Protocol Analytic Code Undecided - It is not yet known if there will be a plan to Undecided - It is not yet known if there will be a plan to make this available make this available Statistical Analysis Plan Data Dictionary Undecided - It is not yet known if there will be a plan to Undecided - It is not yet known if there will be a plan to make this available make this available